Overhauling Industry-Sponsored Studies

Major pharmaceutical companies have agreed to a handful of recommendations aimed at increasing the transparency of clinical trials they fund.

By Bob Grant | May 23, 2012

Wikimedia Commons, Adam from UK

WIKIMEDIA COMMONS, ADAM FROM UK

All clinical trial findings—even negative ones—will be made public, author contributions to manuscripts will be made clear, and study authors will have full access to all trial data in industry-funded clinical trials if a list of recommendations hashed out by editors at top medical journals and eight major pharmaceutical companies are actually implemented.

A team of 11 authors from the worlds of Big Pharma and biomedical publishing listed 10 such recommendations in a recent article that ran in the current issue of Mayo Clinic Proceedings. The recommendations arose from the Medical Publishing Insights and Practices Initiative, launched in 2008, which includes input from representatives at Merck, Amgen, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Pfizer, and Takeda, as well as editors from 65 biomedical journals, among them The Lancet and the Journal of Clinical Oncology, and other members of the International Society for Medical Publication Professionals.

The eight pharmaceutical companies all affirmed their commitment to the recommendations, such as ensuring that clinical studies and publications address clinically important questions, improving understanding and disclosure of authors’ potential conflicts of interest, educating authors on how to develop quality manuscripts and meet journal expectations, reporting adverse event data more transparently and in a more clinically meaningful manner, and transparently reporting statistical methods used in analyses, among others.

But the proof of Big Pharma's commitment to these principles will, as always, be in the pudding. "The [recommendations] all seem fine,” Jerome Kassirer, former editor-in-chief of The New England Journal of Medicine told American Medical News. "The question is whether the pharmaceutical companies will practice what they preach. They don’t always do this, as is evident from the multiple multimillion-dollar suits we hear about, year after year."

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It is also absolutely essential for all PharmaÂ sponsoredÂ studies to present theÂ resultsÂ in an understandable manner to anyone, especially the much despised "non-scientist gradeÂ medicalÂ people". The presentation statistics in any peer reviewed journal mustÂ include NumberÂ neededÂ to treat to achieve the desired benefit and the number needed to harm. Â This information isÂ oftenÂ hidden inside tortured data. I am surprised at the number of reviewers who let this pass.Â Â